This invention relates to an instrument and method of its use for tubal insufflation of the Fallopian tubes of a female primate.
It is well known that ambient air insufflation may be used to create a pneumoperitoneum in humans. Additionally, the use of gas such as carbon dioxide was first introduced in 1924. However, it was also observed that use of air in the body produces more post operative patient discomfort than carbon dioxide. For a further discussion of the subject, see the article by Diaz, Atwood and Laufe entitled "Laparoscopic Sterilization with Room Air Insufflation: Preliminary Report" appearing in the International Journal of Gynaecol Obstete 18, pages 119-122, 1980.
It has also been observed that carbon dioxide has been used in the Rubin Test and if the tubes are patent, the gas upon leaving the Fallopian tubes, enters the peritoneal cavity. The release of this gas may produce some pain in one or both shoulders of the patient. If the manometer used with the Rubin Test registers less than 100 millimeters Hg, the tubes are patent and if the test shows it to be between 120 and 130 millimeters Hg there may be stenosis or stricture but complete occlusion is not detected. If the test pressure rises to 200 mm. Hg, the fallopian tubes are determined to be completely occluded. A further disclosure of this particular test is found in JAMA, Nov. 4, 1983--Vol. 250 and is a reprint from an article published September, 1920 entitled "The Nonoperative Determination of Patency of Fallopian Tubes" by I. C. Rubin, M.D.
Additionally, there are certain mechanisms and structures disclosed in recent patents which are relevant to the present invention, such as U.S. Pat. No. 4,182,328 by Bolduc and Dickhudt entitled "Dispensing Instrument and Method". This instrument and method dispenses fluids and fluid like materials into the uterus and Fallopian tube canals. The instrument described therein has an elongated probe with a forward end carrying an expandable balloon assembly. A dispensing structure located within the housing of the instrument is used to expand the balloon assembly and discharge drug material into the uterine cavity. The drug material is stored in a container accommodated by the dispensing apparatus.
The teachings of U.S. Pat. No. 4,182,328 are unsuitable for use in determining the patency of the fallopian tubes of a patient. For instance, there is no part of the mechanism adapted to receive a predetermined quantity of gas, nor is there any means visible for detecting the condition of patency of the Fallopian tubes.
It is therefore a general object of this invention to provide an instrument and method of injecting carbon dioxide into the Fallopian tube canals and determining their patency directly from the instrument.
It is still another object to the invention to permit external charging and discharging of the instrument from an external source of gas.
It is a further object of the invention to expand and contract a balloon within the uterine cavity in conducting a patency test upon a female primate.
It is yet another object of the invention to use two separate and distinct supplies of gas in performing the patency test using the invention.
It is still a further object of this invention to permit charging of the instrument with carbon dioxide gas but prevent such charging of the instrument after the gas has been released in the patency test.
It is still a further object of this invention to introduce no more than 55 cubic centimeters of carbon dioxide under a maximum of 200 millimeters of mercury into the uterine cavity and connecting Fallopian tubes.
It is still an object of the invention to provide a patency indicator that has a moving member and an indicia scale to measure the openness of Fallopian tube canals.
It is yet another object of the invention to carry out the steps of injecting the carbon dioxide gas and determining how much gas escapes as a measure of the openness of the Fallopian tubes.